Quadruple Fortified Salt Clinical Trial

What Was Tested

The trial (not phased) is built around Cyanocobalamin (Vitamin B12) for anemia.

Despite the fact that there are several causes of anemia, the most important causes are due to micronutrients deficiency, namely iron, Folic acid and Vitamin B12.

Low intakes of these micronutrients consequently affect a woman's health, pregnancy outcome and the nutritional status of breast-fed children.

It had three arms (groups): Arm 1 (active comparator), Arm 2 (active comparator) and Arm 3 (sham comparator).

The registry classes the interventions as combination product.

More on the Plan

Anaemia is the low level of Haemoglobin based on the location.

Who Took Part

174 actual participants took part.

It was open to people of any sex aged from 18 years up to 49 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Able to eat food cooked with salt. Able to give consent.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: planning to become pregnant within the study period,; chronically ill,; have haematological diseases during study time,.

How the Study Was Run

Design: randomized, factorial and triple-blind.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the anemia participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2019-08-23 with completion listed for 2020-12-31.

It ran at 1 site in Tanzania.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Haemoglobin level (time frame: 10 months of consuming fortified salt).

It also tracked 1 secondary outcome, for example Iron store replenishment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 174 people with anemia.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, Anemia research.